Optimizing beta blocker dosage for women using a wearable heart monitor

Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator

This study is testing whether using a wearable heart monitor can help doctors find the right doses of beta blockers and ivabradine for women with cardiomyopathy to keep their heart rates in a healthy range.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Zoll Medical Corporation (Industry-sponsored)
• Locations: 4 sites (Cincinnati, Ohio and 3 other locations)
• Trial ID: NCT04504188 on ClinicalTrials.gov

What this trial studies

This pilot study aims to optimize beta blocker and ivabradine dosages in female patients with cardiomyopathy by monitoring their heart rate using a wearable cardioverter defibrillator (WCD). Participants will wear the WCD for three months, during which their heart rate will be continuously tracked to ensure it averages below 70 beats per minute at night. Healthcare providers will receive regular reports on heart rate trends, allowing for timely adjustments to medication based on guideline-directed therapy. The study compares the outcomes of this approach to historical controls to assess its effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adult female patients aged 18 and older with newly diagnosed ischemic or non-ischemic cardiomyopathy and a low ejection fraction.

Not a fit: Patients with contraindications to beta-blocker therapy or those with permanent atrial fibrillation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart rate control and better management of cardiomyopathy in women.

How similar studies have performed: While this approach is innovative, similar studies focusing on heart rate optimization in heart failure patients have shown promising results.

Eligibility criteria

Inclusion Criteria for Screening Phase:

* Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF ≤ 35% at the time of WCD prescription.
* Patients prescribed the WCD for an intended 90 ± 14 days of use.
* Patients have used the WCD for no more than 14 days from the day of consent.
* Patients 18 years of age or older at the time of consent.

Inclusion Criteria for Continuation Phase:

-After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours/day) are eligible to continue.

Exclusion Criteria for Screening Phase:

* Patients with a known contraindication or intolerance to beta-blocker therapy.
* Patients with permanent atrial fibrillation.
* Patients who have a pacemaker.
* Patients with a current or prior implantable cardioverter defibrillator (ICD).
* Patients who are self-reporting to be pregnant.
* Patients with known congenital or inherited heart disease.
* Patients participating in another interventional clinical trial.
* Patients not expected to live longer than 3 months.

Exclusion Criteria for Continuation Phase:

-Patients ending WCD use within the first two weeks of use.

Where this trial is running

Cincinnati, Ohio and 3 other locations

• TriHealth Hatton Research Institute — Cincinnati, Ohio, United States (Recruiting)
• Texas Cardiology Associates of Houston — Kingwood, Texas, United States (Terminated)
• CardioVoyage — McKinney, Texas, United States (Recruiting)
• Camc — Charleston, West Virginia, United States (Terminated)

Study contacts

• Principal investigator: Valentina Kutyifa, MD PHD — University of Rochester
• Study coordinator: Mike Osz

Conditions Cardiomyopathies; Heart Failure